Treatment strategy for non-responders to 100MG subcutaneous mepolizumab

Abstract

Disclosed herein are methods of treating severe glucocorticoid-dependent eosinophilic asthma in a subject whose asthma has been inadequately controlled with subcutaneously-administered mepolizumab. Also provided are methods of predicting responsiveness to anti-IL-5 antibody treatment in a subject having severe glucocorticoid-dependent eosinophilic asthma.

What is claimed: 
     
       1. A method of treating severe glucocorticoid-dependent eosinophilic asthma in a subject, the method comprising:
 intravenously administering to the subject about 3 mg/kg of reslizumab, wherein 
 prior to the administering, the subject's symptoms were inadequately controlled with subcutaneously-administered mepolizumab and the subject exhibited a forced expiratory volume in one second (FEV 1 ) of 32.8% to 62.4% and/or an asthma control questionnaire (ACQ) score of 0.64 to 3.44; and 
 following the administering, the subject exhibits a clinically significant improvement in FEV 1  and ACQ, and a statistically significant reduction in sputum eosinophil levels and/or blood eosinophil counts. 
 
     
     
       2. The method of  claim 1 , wherein, prior to the administering, the subject had a sputum eosinophilia level of greater than 3%. 
     
     
       3. The method of  claim 1 , wherein, prior to the administering, the subject's blood eosinophil levels were greater than 300/μl. 
     
     
       4. The method of  claim 1 , wherein, prior to the administering, the subject received subcutaneously-administered mepolizumab for at least 1 year. 
     
     
       5. The method of  claim 4 , wherein the subject received 100 mg of subcutaneously-administered mepolizumab every four weeks. 
     
     
       6. The method of  claim 1 , wherein the reslizumab is administered every four weeks. 
     
     
       7. The method of  claim 1 , wherein, following the administering, the level of sputum eosinophils are less than 3%, the blood eosinophil counts are less than 300/μl, or both. 
     
     
       8. The method of  claim 7 , wherein the blood eosinophil counts are at least 50% compared to a pretreatment level. 
     
     
       9. The method of  claim 1 , wherein the clinically significant improvement in FEV 1  comprises a greater than or equal to 20% increase compared to a control. 
     
     
       10. The method of  claim 1 , wherein the clinically significant improvement in ACQ comprises a greater than or equal to 50% increase compared to a control.